United Spinal Association Jobs

JOB REQUIREMENTS: Summary of role The Production Engineer supports cGMP manufacturing. The Production Engineer is responsible for troubleshooting unexpected manufacturing events; preparing, conducting, and evaluating continued process verification activities; and providing on-going support of commercial manufacturing. The Production Engineer works closely with Research and Development, Manufacturing, Quality Assurance and Regulatory Affairs, EHS, and Engineering to ensure robust production of cGMP API materials. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile. Your Responsibilities * Writes protocols and reports needed to support investigations, process changes, and equipment modifications. * Supports the creation and maintenance of cGMP production records. * Provides training to manufacturing staff on manufacturing procedures. * Provide technical on-the-floor support of commercial and validated processes. * \"Process owner\" of commercial products. Support client interactions for these products. * Evaluates product impact of process excursions outside proven acceptable ranges. * Seek opportunities to improve process performance within process ranges defined by large-scale equipment capabilities. * Understands relationships between process yield and product quality to achieve process optimization. * Troubleshoots unexpected events during cGMP manufacturing, assists in investigating and documenting process deviations and CAPAs. * Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA, and DEA. Complies with all company and site policies and procedures. Requirements for Role * Requires a bachelor\'s degree in engineering, Chemical Engineering strongly preferred. * Previous work experience in a regulated environment a plus. What We Offer We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development. Diversity and Inclusion Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law. Location This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene. Why Consider Sterling? Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years\' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services. We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients. Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjQ0NzA0Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl cmFrLmNvbQ ***** APPLICATION INSTRUCTIONS: Apply Online: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjQ0NzA0Ljg3NzBAc3Rlcmxpbmdwc2xjb21wLmFwbGl0cmFrLmNvbQ